Systems, methods, and apparatuses for securely dispensing one or more prescribed substances to a securely identified intended user

ABSTRACT

Systems, methods, and apparatuses for securely dispensing one or more prescribed substances at a given time and/or date are disclosed herein. In certain embodiments, a pill dispensing device may include a generally tamper-proof portable housing. A replaceable cartridge may be configured to be removably disposed within the portable housing. The replaceable cartridge also may be generally tamper-proof. The portable housing and/or the replaceable cartridge may be operable to dispense a predefined amount of a prescribed substance at a given time and/or date.

CROSS-REFERENCE TO RELATED APPLICATION

The disclosure claims priority to and the benefit of U.S.non-provisional application Ser. No. 14/215,837, filed Mar. 17, 2014,which claims priority to and the benefit of U.S. provisional applicationNo. 61/788,492, filed Mar. 15, 2013, which are both hereby incorporatedby reference herein in their entirety.

FIELD

The disclosure generally relates to medication dispensing devices andmore particularly relates to systems, methods, and apparatuses fordispensing one or more medication substances to a securely identifiedintended user.

BACKGROUND

Unintended use of prescription medications by the intended user orothers is a serious problem. The misuse of legitimately prescribedmedications such as painkillers, stimulants, tranquilizers, sedatives,and steroids kills tens of thousands of Americans and costs the U.S.healthcare system more than $100 billion a year. The biggest impact isfrom opiate painkillers, but deaths and injuries are often caused bysimultaneous exposure to multiple classes of Controlled Substances anddrugs of potential abuse. Opiates remain the medications of choice totreat legitimate acute and chronic pain. In the U.S. alone, 130 millionprescriptions were written in 2010 for hydrocodone, which has become awidespread source of abuse and drug trafficking. All told, approximately500 million Controlled Substance prescriptions are written in the U.S.each year. According to recent congressional data, prescription drugabuse is the leading cause of accidental death in the U.S., nowexceeding traffic accidents, and also exceeding deaths from heroin andcocaine, combined. Approximately 60% of prescribed medication is nottaken as directed.

In 2010, over 38,000 unintentional drug overdose deaths occurred in theUnited States, 60% of those involving prescription medications.Prescription drug abuse is the fastest growing drug problem in theUnited States. The increase in unintentional drug overdose death ratesin recent years has been driven by increased use of a class ofprescription opioid analgesics. In addition, recent data suggests thatfor every unintentional overdose death related to an opioid analgesic,10 persons are admitted for substance abuse treatment, 32 visitemergency departments, 130 report drug abuse or dependence, and 825report nonmedical uses of opioid analgesics. Prescription drugs are thesecond-most abused category of drugs after marijuana.

Medications, such as opioid analgesics and narcotics, may be prone toabuse or diversion, for instance taken in excess or diverted and sold toothers who would abuse the medication. The two main populations in theUnited States at risk for prescription drug overdose are theapproximately 9 million persons who report long-term medical use ofopioids and the roughly 12 million persons who report non-medical use(i.e., use without a prescription or medical need) annually. In anattempt to treat patient pain better, practitioners have greatlyincreased their rate of opioid prescribing over the past decade. Personswho abuse opioids have learned to exploit this new practitionersensitivity to patient pain, and clinicians struggle to treat patientswithout overprescribing these drugs. The regulatory response to informthe prescriber about the potential abusers recent prescription historythrough an updated electronic health record is currently part of theattempt to address one aspect of this problem. This, however, still doesnot address the availability of the entire contents of a legitimatelyprescribed opioid capped bottle to anyone once it's opened, in anyamount, at any frequency. The chain of command for the drug of potentialabuse is lost once it leaves the pharmacy.

It is desirable to prevent the misuse of medications by intended usersand also to ensure correct dispensing of prescription medications. Itwould be useful to provide a low-cost portable dispenser and monitoringsystem to verify that medications stored therein are not taken in excess(i.e., abused) and are only taken at the prescribed interval and dose.It also would be useful to provide a portable dispenser and monitoringsystem to verify that medications stored therein are removed only by thepatient or another authorized person in order to prevent drug abuse anddiversion.

SUMMARY

Some or all of the foregoing needs and/or problems may be addressed withone or more of the embodiments of the present disclosure. In certainembodiments, the systems, methods, and apparatuses for securelydispensing one or more prescribed substances (i.e., a prescribed drug)at a given time and/or date or on demand to a securely identifiedintended user may include a generally tamper-proof portable housing. Insome instances, a replaceable cartridge or the like may be configured tobe removably disposed within the portable housing. In other instances,the cartridge may be omitted. The cartridge also may be generallytamper-proof. The cartridge and/or the portable housing may be operableto dispense a predefined amount of a prescribed substance at a giventime and/or date or on demand to a securely identified intended user.The cartridge may be operable to store information associated with aprescribed substance and/or a patient. The apparatus may be loaded withone or more prescription medications by a pharmacist or other trainedpersons at a pharmacy interaction or at a mail-order pharmacy. Theapparatus may include encrypted secure identifiable informationconnecting the intended user to the apparatus, the contents, and/or thedispensing dose, frequency and/or duration. That is, the apparatus maybe configured to only dispense to the intended user upon secureidentification thereof and will not dispense to others. Examples ofidentity strategies may include, but are not limited to, fingerprintidentification, pin code encryption, face-recognition, multi-sourceidentification software, and the like. Any identification means may beused herein.

The device may interact with a medication and information loading deviceor docking station at the pharmacy counter or elsewhere, into which thepharmacist or the patient may load the prescribed medication, and alsointo which the dispensing apparatus is inserted to receive themedication. This loading system may include identification encryptionmethods to contemporaneously securely connect the contents to theidentified user. Alternatively, the apparatus may be loaded with acartridge that contains medication previously loaded by the pharmacist.The cartridge may also be inserted into a loading system or dockingstation at the pharmacy counter or elsewhere, into which the dispensingapparatus also may be inserted to receive the cartridge. This loadingsystem may include identification encryption methods tocontemporaneously securely connect the cartridge and contents to theidentified user.

Other features and aspects of the disclosure will be apparent or willbecome apparent to one with skill in the art upon examination of thefollowing figures and the detailed description. All other features andaspects, as well as other system, method, and assembly embodiments, areintended to be included within the description and are intended to bewithin the scope of the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description is set forth with reference to the accompanyingdrawings. The use of the same reference numerals may indicate similar oridentical items. Various embodiments may utilize elements and/orcomponents other than those illustrated in the drawings, and someelements and/or components may not be present in various embodiments.Elements and/or components in the figures are not necessarily drawn toscale. Throughout this disclosure, depending on the context, singularand plural terminology may be used interchangeably.

FIG. 1 schematically depicts an example system and apparatus forsecurely dispensing one or more prescribed substances at a given timeand/or date in accordance with one or more embodiments of thedisclosure.

FIG. 2 schematically depicts an example system and apparatus forsecurely dispensing one or more prescribed substances at a given timeand/or date in accordance with one or more embodiments of thedisclosure.

FIG. 3 is a flow diagram depicting an illustrative method for securelydispensing one or more prescribed substances at a given time and/or datein accordance with one or more embodiments of the disclosure.

FIG. 4 is a flow diagram depicting an illustrative method for securelydispensing one or more prescribed substances at a given time and/or datein accordance with one or more embodiments of the disclosure.

FIG. 5 schematically depicts an example system and apparatus forsecurely dispensing one or more prescribed substances at a given timeand/or date in accordance with one or more embodiments of thedisclosure.

FIG. 6 schematically depicts an example system and apparatus forsecurely dispensing one or more prescribed substances at a given timeand/or date in accordance with one or more embodiments of thedisclosure.

FIG. 7 depicts an example apparatus for securely dispensing one or moreprescribed substances at a given time and/or date in accordance with oneor more embodiments of the disclosure.

FIG. 8 depicts an example apparatus for securely dispensing one or moreprescribed substances at a given time and/or date in accordance with oneor more embodiments of the disclosure.

FIG. 9 depicts an example apparatus for securely dispensing one or moreprescribed substances at a given time and/or date in accordance with oneor more embodiments of the disclosure.

FIG. 10 depicts an example apparatus for securely dispensing one or moreprescribed substances at a given time and/or date in accordance with oneor more embodiments of the disclosure.

FIG. 11 depicts an example apparatus for securely dispensing one or moreprescribed substances at a given time and/or date in accordance with oneor more embodiments of the disclosure.

FIG. 12 depicts an example apparatus for securely dispensing one or moreprescribed substances at a given time and/or date in accordance with oneor more embodiments of the disclosure.

FIG. 13 depicts an example apparatus for securely dispensing one or moreprescribed substances at a given time and/or date in accordance with oneor more embodiments of the disclosure.

FIG. 14 depicts an example apparatus for securely dispensing one or moreprescribed substances at a given time and/or date in accordance with oneor more embodiments of the disclosure.

FIG. 15 depicts an example apparatus for securely dispensing one or moreprescribed substances at a given time and/or date in accordance with oneor more embodiments of the disclosure.

FIG. 16 depicts an example apparatus for securely dispensing one or moreprescribed substances at a given time and/or date in accordance with oneor more embodiments of the disclosure.

FIG. 17 depicts an example apparatus for securely dispensing one or moreprescribed substances at a given time and/or date in accordance with oneor more embodiments of the disclosure.

FIG. 18 depicts an example apparatus for securely dispensing one or moreprescribed substances at a given time and/or date in accordance with oneor more embodiments of the disclosure.

DETAILED DESCRIPTION

Overview

Described below are embodiments of systems, methods, and apparatuses forsecurely dispensing one or more prescribed substances (e.g., a pluralityof tablets, pills, or capsules) at a given time and/or date to asecurely identified intended user and/or in accordance with a prescribeddosage schedule. Such embodiments may protect the prescribed substancewithin a portable housing that is generally tamper-proof and may only beopened by authorized personnel, such as a physician, a pharmacist, or asecurely identified intended user. In addition, certain embodiments mayinclude a replaceable cartridge (such as a cartridge, magazine,container, bottle, etc.) with one or more segments to hold predefinedamounts of the prescribed substance. The replaceable cartridge may beinserted into the portable housing. The cartridge may be operable tostore information associated with a prescribed substance and/or apatient, wherein the information can be read or otherwise obtained whenneeded by the portable housing. Moreover, the replaceable cartridge maybe generally tamper-proof and only accessible by authorized personnel.Furthermore, certain embodiments may include a loading device operableto receive a replaceable cartridge and/or the apparatus itself forloading of medications and identity encryption. The loading device alsomay be operable to communicate information associated with a prescribedsubstance and/or a patient. Moreover, the loading device may be operableto insert a prescribed substance into the replaceable cartridge and/orthe apparatus, depending on the embodiment.

In some instances, the prescribed substance may be an opioid drug orother medications of potential abuse or the like, for which it isdesirable to prevent abuse, misuse, or diversion to others than theprescribed patient. The prescribed substance, however, may be any drug,medication, prescription, and/or treatment. For example, the prescribedsubstance may include one or more solid drug units, such as tablets,capsules, and/or pills. The apparatus may dispense one or more differenttypes of medications. In one example, stimulants, sleep medications,de-tox medications, suboxone, benzodiazepines, and/or anti-anxietymedications may be used herein.

In certain embodiments, the apparatus may include a pill dispensingsystem for securely dispensing one or more prescribed substances at agiven time and/or date to a securely identified intended user. In oneexample, the pill dispensing system may dispense a range of substancesat a range of time intervals, such as, e.g., 1-2 tablets every 4-6hours. Other dispensing ranges and timetables are possible and arewithin the scope of the disclosure.

The pill dispensing system may include a portable housing, a replaceablecartridge, a processor, a memory, a power source, and/or a communicationinterface, although some components may be omitted and others may beadded. In some instances, the pill dispensing device may comprise aspring loaded dispenser that is configured to dispense medication. Theportable housing may protect the intended medication, the replaceablecartridge, the processor, the memory, the power source, and/or thecommunication interface from tamper attempts. In some instances, theportable housing may be sized and shaped to be carried by a patient. Forexample, the portable housing may be configured to be held in the handof the patient or carried in the pocket of the patient. In this manner,the power source may include at least one battery or the like.

The portable housing may include an opening for inserting and/orremoving the replaceable cartridge and/or the medication therein. Theopening may be generally tamper-proof and only accessible by authorizedpersonnel. In this manner, only authorized personnel may insert and/orremove the replaceable cartridge and/or the medication to and from theportable housing. For example, the opening may include a lockingmechanism or the like. In some instances, the locking mechanism may be amechanical lock, a biometric lock, an electronic lock, or a combinationthereof. For example, a person authorized to insert and/or remove themedication and/or replaceable cartridge, such as a physician, apharmacist, or to a securely identified intended user, may be requiredto enter a code, provide a finger print, and/or use a key to access theopening to remove or insert the replaceable cartridge and/or themedication.

Similarly, a person authorized to accept or be the recipient of thedispensed medication contents, such as the intended patient orauthorized user, may be required to enter a code, provide a fingerprint, utilize other forms or encrypted identification, and/or use a keyto be dispensed the intended medication at the intended dose, frequency,and/or quantity prescribed. Moreover, the locking mechanism may be voiceor otherwise activated. Other locking mechanisms may also be used toprevent tampering with the medication or apparatus. The apparatus maycontain notification systems to alert the operating system directly orindirectly to tamper attempts or apparatus destruction.

The replaceable cartridge and/or apparatus may be operable to dispense apredefined amount of a prescribed substance at a given time and/or dateto a securely identified intended user. For example, the replaceablecartridge may cooperate with the portable housing to enable anauthorized patient to access a predefined amount of a prescribedsubstance, i.e., the prescribed dose of the prescribed drug at a giventime and/or date. In other instances, the apparatus (independent of acartridge system) may perform the same function. In certain embodiments,the replaceable cartridge (or the apparatus independent of the cartridgesystem) may hold predefined amounts of prescribed substances and may beconfigured to accept, quantify, collate and/or dispense the intendedmedication to a securely identified intended user. The dispensing of themedication may be at the verified user's discretion, limited to a dosageschedule, or a combination thereof.

In other embodiments, the replaceable cartridge may be an elongatedmember or a wheel-shaped member. In one example, the replaceablecartridge may be a replaceable cartridge with one or more prescribedsubstances within respective compartments. For example, the replaceablecartridge may have a cassette-like configuration. In some instances, thereplaceable cartridge may comprise a medication bottle or the like thatis typically used by pharmacists.

The replaceable cartridge may be generally tamper-proof and onlyaccessible by authorized personnel or a securely identified intendeduser. Further, the apparatus (independent of the cartridge system) mayperform the same functions once loaded by a pharmacist or otherqualified persons. That is, the systems and methods described herein maybe performed by the apparatus and a corresponding insertable cartridge,or alternatively, the systems and methods described herein may beperformed by an apparatus that does not include a cartridge. That is,the apparatus itself houses and dispense the medications to a securelyidentified intended user without the use of a replaceable cartridge.

In certain embodiments, the portable housing and/or the replaceablecartridge may include at least one processor in communication with atleast one memory. The processor and/or memory may includecomputer-executable instructions to operate the power source tomanipulate the replaceable cartridge at the given time and/or date.Further, the communication interface may be operable to receiveinstructions to operate the power source to manipulate the replaceablecartridge at the given time and/or date or at the verified user'sdiscretion. In this manner, based at least in part on thecomputer-executable instructions and/or the communication interface, thereplaceable cartridge and/or the portable housing may be manipulated toenable a securely identified intended user to access a predefined amountof a prescribed substance at a given time and/or date. For example, thereplaceable cartridge may provide a predefined amount of a prescribedsubstance to an access port within the portable housing that isaccessible by the securely identified intended user. In some instances,the securely identified intended user may request that the portablehousing and/or the replaceable cartridge dispense the prescribedsubstance on demand. In such instances, the portable housing and/or thereplaceable cartridge may be configured to monitor how much drug isbeing dispensed over time, and in some instances, may limit thedispensing of the drug if it is being abused.

In some instances, the patient may be required to provide verificationin order to access the prescribed substance. For example, the patientmay be required to enter a code, provide a finger print, utilize otherforms or encrypted identification, and/or use a key to gain entry to theaccess port within the portable housing in order to access theprescribed substance. Any biometric identifier may be used to preventunauthorized access to the prescribed substance by someone other thanthe patient. For example, in some instances, voice or face recognitionsoftware may be used to verify the patient's identity. Other accesscontrols may also be used to prevent unauthorized access to theprescribed substance including, but not limited to, pin-code security orthe like.

In some instances, the pill dispensing system may include a remotemonitoring component, which may receive an indication when the portablehousing, the replaceable cartridge, and/or the intended medication iscompromised. In addition, in certain embodiments, the remote monitoringcomponent may be configured to receive an indication to dispense aprescribed substance at a time and/or date other than a programmed timeand/or date. An alert may be generated and transmitted by the processorand/or the remote monitoring component if the prescribed substance isdispensed at a time and/or date other than a programmed time and/ordate, or if the portable housing and/or the replaceable cartridge iscompromised or opened, or if someone other than the patient accesses orattempts to access the prescribed substance.

In certain embodiments, the remote monitoring component may beconfigured to monitor the on demand dispensing of medication todetermine if the medication is being abused. If it is determined thatthe medication is being abused, the remote monitoring component send asignal to limit the dispensing of the medication or stop the dispensingof the medication altogether.

In one example, if the portable housing and/or replaceable cartridge iscompromised or otherwise dispenses a prescribed substance at a timeand/or date other than a programmed time and/or date, the prescribedsubstance may be rendered inert by the addition or release of a countersubstance that may react with the prescribed substance to render itinert.

Other embodiments may include a time-limited device connection with asupport system by direct interaction through, for example, a USB connector the like to confirm apparatus function and the absence of a faileduse or tamper attempt at predefined intervals (e.g., daily or everyother day, etc.). Such a connection may be required for the apparatus tofunction properly. In other instances, the pill dispensing system maycommunication over a network (e.g., wireless, cellular, etc.) or thelike.

In certain embodiments, authorized personnel, such as a physician or apharmacist, may insert the replaceable cartridge (e.g., a pill bottle orthe like) into the portable housing. In some instances, the replaceablecartridge may be readymade. That is, the replaceable cartridge may beprefilled with prescribed substances from the manufacturer. In otherinstances, the authorized personnel, e.g., a pharmacist, may prepare thereplaceable cartridge for insertion into the portable housing. That is,the authorized personnel may provide a predefined amount of prescribedsubstance in the compartments of the replaceable cartridge. In certainembodiments, the authorized personnel may program the processor and/ormemory associated with the replaceable cartridge to communicate with theportable housing to provide the patient with a predefined amount of aprescribed substance at a given time and/or date. For example, thereplaceable cartridge may provide a predefined amount of a prescribedsubstance to an access port within the housing that is accessible by thepatient at the given time and/or date based on the instructions providedby the authorized personnel.

In other embodiments, authorized personnel, such as a physician or apharmacist, may insert the prescribed substances directly into theportable housing. This is, in this embodiment, the cartridge may beomitted and the portable housing itself may include all of thefunctionality described herein. For example, the authorized personnelmay provide a predefined amount of prescribed substance in the portablehousing. In certain embodiments, the authorized personnel may programthe processor and/or memory associated with the portable housing toprovide the patient with a predefined amount of a prescribed substanceat a given time and/or date. In other instances, the verified user maydispense the medication at will. In some instances, the patient may berequired to provide identification information in order to obtain theprescribed substance.

In some embodiments, a loading device may be provided to receive areplaceable cartridge and to insert a prescribed substance into thereplaceable cartridge. In other instances, the loading device mayreceive the apparatus, such as the portable housing. The loading devicemay be operated by a pharmacist or other personnel responsible fordistributing a prescribed substance or otherwise loading the replaceablecartridge and/or the portable housing with the prescribed substance. Theloading device may include a reader and/or programming device tofacilitate communication with the replaceable cartridge and/or theportable housing. The loading device (or docking station) may be locatedat a pharmacy counter or elsewhere. The pharmacist or the patient mayinsert the prescribed medication into the loading device. Moreover, thepharmacist or the patient may insert the cartridge and/or dispensingapparatus into the loading device to receive the medication. The loadingdevice may then load the dispensing apparatus with medication. Theloading device may include identification encryption functionality tocontemporaneously securely associate the contents to the identifieduser. Alternatively, the apparatus may be loaded with a cartridge thatcontains medication previously loaded by the pharmacist.

In certain instances, when a paper and/or electronic prescription isreceived, prescription information and/or patient information may betransmitted or otherwise input to the loading device. The loading devicemay transmit some or all of the prescription information and/or patientinformation to a replaceable cartridge or the portable housing when thereplaceable cartridge or the portable housing is in communication withthe loading device. Prescription information may include a name of aprescribed substance, a dosage regimen, a patient's contact information,a prescriber's contact information, a pain scale, etc.

As noted above, in some embodiments, the apparatus may not contain acartridge. In this manner, the apparatus may be inserted into a loadingor docking station, which temporarily engages the apparatus formedication loading, identity encryption for the intended user,encryption of contents, and prescriptive information. The loading devicemay be accessed on one side by the pharmacist (or other qualifiedpersons) for medication loading and by the intended user on the otherside. That is, the intended user may insert the apparatus on one side ofthe loading device and the pharmacist may load medication on the otherside of the loading device. In this manner, the loading device may belocated, for example, on the pharmacy counter or other location such asa doctor's office or dispensary. This configuration may ensure that thepatient does not have unauthorized access to the medication.

Although the systems and methods described herein are discussed inrelation to controlled substances, any material, substance, article,etc., (e.g., precious metals, jewels, or the like) may be used herein.That is, the systems and methods described herein may be used inconjunction with the secure transfer of any high value substance or thelike. For example, the systems and methods described herein may be usedto securely transport and dispense small unit, high-value objects, suchas jewels, gemstones, microelectronics, or anything else.

These and other embodiments of the disclosure will be described in moredetail through reference to the accompanying drawings in the detaileddescription of the disclosure that follows. This brief introduction,including section titles and corresponding summaries, is provided forthe reader's convenience and is not intended to limit the scope of theclaims or the proceeding sections. Furthermore, the techniques describedabove and below may be implemented in a number of ways and in a numberof contexts. Several example implementations and contexts are providedwith reference to the following figures, as described below in moredetail. However, the following implementations and contexts are but afew of many.

Illustrative Embodiments

FIG. 1 schematically depict a pill dispensing device 100 for securelydispensing one or more prescribed substances at a given time and/or dateto a securely identified intended user. The pill dispensing device 100may be configured to protect the prescribed substance within a portablehousing 102 that is generally tamper-proof and may only be opened formedication loading by authorized personnel, such as a physician, apharmacist, or a securely identified intended user. In some instances,the portable housing 102 may be sized and shaped to be carried by apatient. For example, the portable housing 102 may be configured to beheld in the hand of the patient and/or carried in the pocket of thepatient. In one example embodiment, the housing is from about 3 inchesto about 8 inches long, from about 2 inches to about 6 inches wide, andfrom about 0.25 inches to about 1.5 inches thick. Other dimensions arewithin the scope of the disclosure.

In certain embodiments, the portable housing 102 may include a memory104, a processor 106, a communication interface 108, a power source 110(e.g., a battery), and/or a remote monitoring component 112. Moreover,in some instances, the pill dispensing device 100 may include areplaceable cartridge 114 configured to be inserted and/or removed fromthe portable housing 102, although in other embodiments the cartridge114 may be omitted. The portable housing 102 may protect the memory 104,the processor 106, the communication interface 108, the power source110, the remote monitoring component 112, the prescribed substance,and/or the replaceable cartridge 114 from tamper attempts.

In some instances, the communication interface 108 may comprise agraphical user interface or the like. The communication interface 108may enable a user to interact with the pill dispensing device 100 tocontrol, dispense, monitor, communicate with, and/or observe the variousaspects of the device. For example, the communication interface 108 maybe operable to receive instructions to operate the power source 110 tomanipulate the replaceable cartridge 114 at a given time and/or date tosecurely dispense one or more prescribed substances to a securelyidentified intended user. In some instances, the communication interface108 may be operable to receive instructions from the securely identifiedintended user to dispense one or more prescribed substances on demand.

In addition, the communication interface 108 may provide alerts and/orreminders to the user, such as a green light indicating that a pill hasbeen dispensed or can be dispensed if needed, a yellow light to indicatean approaching dispensing interval, and a red light to indicate theabsence of accessibility. Moreover, the communication interface mayinclude verbal commands, haptic feedback, and/or written commands. Otheralerts and/or reminders may be used. In some instances, thecommunication interface 108 may include a monitor and/or controls.Further, the communication interface 108 may be configured to receiveinput from a user of the pill dispensing device 100. For example, theuser may provide an indication that a pill has been taken, or the usermay request pills.

The communication interface 108 may include functionality to verify thepatient's identity. That is, the patient may be required to provideverification in order to access the prescribed substance within the pilldispensing device 100. For example, the patient may be required to entera code, provide a finger print, provide face or voice recognition,activate an identity sequence or verify themselves through an attachedhandheld phone or computer, and/or use a key to gain entry to an accessport 132 within the portable housing 102 in order to access theprescribed substance. Any biometric identifier may be used to preventunauthorized access to the prescribed substance. For example, in someinstances, voice or face recognition software may be used to verify thepatient's identity. In this manner, the communication interface 108 mayinclude a camera, touch screen, receiver, microphone, etc. Other accesscontrols may also be used to prevent unauthorized access to theprescribed substance. In this manner, only securely identified intendedusers may have access to the medication.

In certain embodiments, the remote monitoring component 112 may includewireless functionality to facilitate wireless communication with one ormore devices over a network 116. For example, the pill dispensing device100 may be in communication with an authorized user system 118 (e.g., apharmacy or hospital) over the network 116. The authorized user system118 may include a database 119 that includes information associated withthe pill dispensing device 100, such as medication type, dosage, patientinformation, prescriber information, pain scale etc. In this manner, anoperator of the authorized user system 118 may remotely communicatewith, transmit to, receive from, monitor, and/or control various aspectsof the pill dispensing device 100.

In one example, the authorized user system 118 may increase or decreasedosage based on the patient's condition, such as an increased pain levelor improved condition. In another example, the authorized user system118 may receive an alert if the prescribed substance is dispensed at atime and/or date other than a programmed time and/or date, or if theportable housing 102 and/or replaceable cartridge 114 are compromised oropened. In yet another example, the authorized user system 118 mayreceive a report (hourly, daily, weekly, etc.) regarding medicationusage. Moreover, the authorized user system 118 may remotely alter themedication schedule of the pill dispensing device 100. In someinstances, the authorized user system 118 may monitor the dispending ofmedication to determine if the medication is being abused. In suchinstances, the authorized user system 118 may limit or prevent thedispensing of medication.

In certain embodiments, interaction of the pill dispensing device 100with the network 116 may be direct through a physical connection orindirect via a wireless network. In one example, in the event of amedicine recall and/or if the medication has expired, the pilldispensing device 100 can be locked and/or the patient may be notified.Moreover, the pill dispensing device 100 may include a GPS module or thelike. In this manner, the location of the pill dispensing device 100 maybe monitored, or if the pill dispensing device 100 is lost or stolen, itmay be tracked down.

In some instances, the pill dispensing device 100 may be in direct orindirect communication with a user device 120 (e.g., a cell phone,laptop, tablet, and/or a mobile application thereon, etc.) over thenetwork 116. In this manner, the user device 120 may remotelycommunicate with, transmit to, receive from, monitor, and/or control thevarious aspects of the pill dispensing device 100 described herein. Forexample, alerts may be transmitted to the user device 120 to remind thepatient to take a pill and/or provide the patient with medicationinstructions. In addition, the patient may be required to enter a code,answer a question, activate an identity encryption sequence, use face orany form of biometric recognition, and/or speak into the user device 120in order to receive a dosage of the prescribed substance from the pilldispensing device 100. In some instances, the user device 120 may berequired to be within a certain proximity of the pill dispensing device100 in order for the pill dispensing device 100 to dispense medication.That is, the user device 120 (such as a cell phone or the like) may beassociated with an intended patient. In other instances, the user device120 may generate, transmit, and/or receive reports regarding adherence,attempts to access medications, amount of medication dispensed, symptomlevels, recall information etc.

The portable housing 102 may include an opening 122 for inserting and/orremoving the replaceable cartridge 114 and/or the medication therein.The opening 122 may be generally tamper-proof and only accessible byauthorized personnel and/or a securely identified intended user. In thismanner, only authorized personnel may insert and/or remove thereplaceable cartridge 114 and/or medication into the portable housing102. For example, the opening 122 may include a locking mechanism 124 orthe like. In some instances, the locking mechanism 124 may be amechanical lock, a biometric lock, an electronic lock, or a combinationthereof. For example, a person authorized to insert medications directlyinto the apparatus and/or remove a replaceable cartridge 114 may berequired to enter a code, provide a finger print, and/or use a key toaccess the opening 122 to remove or insert the medication and/or thereplaceable cartridge 114. Any biometric identifier may be used. Forexample, in some instances, the locking mechanism 124 may comprise voiceor face recognition software. That is, a person authorized to insertand/or remove the replaceable cartridge 114 may interact with acommunication interface 108 and/or the user device 120 in order tounlock the locking mechanism 124. Other locking mechanisms 124 may alsobe used to prevent tampering with the opening 122.

In certain embodiments, the replaceable cartridge 114 may comprise acartridge with multiple compartments 126 to hold predefined amounts ofthe prescribed substance. For example, in some instances, thereplaceable cartridge 114 may be arranged in a cassette-likeconfiguration as discussed below. In other instances, the cartridge maycomprise a typical pill bottle. The prescribed substances may be thesame or different. In some instances, the prescribed substance may be anopioid drug or the like, for which it is desirable to prevent abuse,misuse, or diversion to others than the prescribed patient. For example,the prescribed substance may include one or more solid drug units, suchas tablets, capsules, or pills. In this manner, the replaceablecartridge 114 may be generally tamper-proof and only accessible byauthorized personnel upon verification thereof. For example, a lockingmechanism (similar to the locking mechanism 124) may be associated withthe replaceable cartridge 114 to prevent access to someone other than asecurely identified intended user.

The portable cartridge, container, bottle, and/or dispensing mechanismmay be configured to accurately meter correct dosage. In some instances,the containers may comprise various sizes (i.e., 30, 60, 90, 120, 180size containers), in which the control unit and dispensing mechanism areof the same size, and the bottles have universal size tops and bottoms,but with different capacities.

The replaceable cartridge 114 may be operable to dispense a predefinedamount of a prescribed substance at a given time and/or date to asecurely identified intended user. For example, the replaceablecartridge 114 may cooperate with the portable housing 102 to enable apatient to access a predefined amount of a prescribed substance at agiven time and/or date to a securely identified intended user. Asdepicted in FIG. 1, the replaceable cartridge 114 may be wheel-shaped.In other embodiments, the replaceable cartridge 114 may be an elongatedmember. In some instances, the replaceable cartridge 114 may be arrangedin a cassette-like configuration as discussed below. The replaceablecartridge 114, however, may be any shape. In one example, thereplaceable cartridge 114 may be a replaceable cartridge with one ormore prescribed substances within respective compartments 126. Thedispensing mechanisms for releasing a dose of drug from the pilldispensing device 100 may reside wholly or partially in the replaceablecartridge 114, the housing 102, or a combination thereof. For example,the dispensing mechanism may be arranged in a cassette-likeconfiguration, a rotational pill exchange, or the like.

In certain embodiments, the replaceable cartridge 114 may include amemory 128 in communication with a processor 130 (or a controller). Inother embodiments, the cartridge may not include any electroniccomponents. The memory 128 and the processor 130 of the replaceablecartridge 114 may be in communication with the memory 104 and theprocessor 106 of the portable housing 102. That is, the replaceablecartridge 114 and the portable housing 102 may cooperatively function tosecurely dispensing one or more prescribed substances at a given timeand/or date to a securely identified intended user. In anotherembodiment, the memory 128 and the processor 130 of the replaceablecartridge 114 may be in communication with a processor associated with aserver, authorized user system 118, and/or user device 120 via one ormore networks 116. In any instance, the processors and/or the memoriesmay include computer-executable instructions to operate the power source110 to manipulate the replaceable cartridge 114 at the given time and/ordate or on demand. For example, the replaceable cartridge 114 mayprovide a predefined amount of a prescribed substance to an access port132 within the portable housing 102 that is generally tamperproof andaccessible by a securely identified intended user.

In certain embodiments, authorized personnel, such as a physician or apharmacist, may insert the replaceable cartridge 114 into the portablehousing 102. In some instances, the replaceable cartridge 114 may bereadymade. That is, the replaceable cartridge 114 may be prefilled withprescribed substances from the manufacturer, such as at a pharmacy orprescribed substance manufacturer. In other instances, the authorizedpersonnel may prepare the replaceable cartridge 114 (such as a pillbottle) for insertion into the portable housing 102. That is, theauthorized personnel may provide a predefined amount of prescribedsubstance in the compartments 126 of the replaceable cartridge 114. Thereplaceable cartridge 114 may be hand loaded and/or configured to befilled by way of an automated process (e.g., loading machine filled).

In certain embodiments, the authorized personnel may program or encodethe processor 130 and/or memory 128 associated with the replaceablecartridge 114 to communicate with the portable housing 102 to providethe patient with a predefined amount of a prescribed substance at agiven time and/or date. For example, the replaceable cartridge 114 mayprovide a predefined amount of a prescribed substance to the access port132 within the portable housing 102 that is accessible by the patient atthe given time and/or date based at least in part on one or moreinstructions provided by the authorized personnel. In other embodiments,prescription information and/or patient information can be programmed orencoded in the processor 130 and/or memory 128 associated with thereplaceable cartridge 114, wherein some or all of the information can beutilized by the portable housing 102 to provide the patient with apredefined amount of a prescribed substance at a given time and/or dateor on demand based on verification of the patient's identity.

In some instances, the replaceable cartridge 114 and/or the portablehousing 102 may include identifier information. The identifierinformation may include, but is not limited to, medication information,dosage information, patient information, prescriber information, usagerestrictions, time stamps, etc. The identifier information may be usedto determine a chain of command regarding the handling of the prescribedsubstance and/or the dispensing of the prescribed substance.

As noted above, the prescribed substance may include an opioid drug orthe like, for which it is desirable to prevent abuse, misuse, ordiversion to others than the prescribed patient. Accordingly, it may bebeneficial to provide information regarding the handling and/or thedispensing of the prescribed substance. For example, in some instances,the processors and/or the memories associated with the portable housing102 and/or the replaceable cartridge 114 may be programmed to includethe identifier information. In other instances, a bar code, QR code,RFID, label, or other readable medium comprising the identifierinformation may be associated with the replaceable cartridge 114 and/orthe portable housing 102. The identifier information may be stored in adatabase, such as database 119 or the like.

In other embodiments, as noted above, all of the functionality describedherein may be performed without a replaceable cartridge 114. That is,the pill dispensing device 100 may be operable to dispense a predefinedamount of a prescribed substance at a given time and/or date or ondemand to a securely identified intended user. For example, the pilldispensing device 100 may enable a patient to access a predefined amountof a prescribed substance at a given time and/or date. In someinstances, the authorized personnel may provide a predefined amount ofprescribed substance in the pill dispensing device 100. The pilldispensing device 100 may be hand loaded and/or configured to be filledby way of an automated process (e.g., loading machine filled).

In other embodiments, the pill dispensing device 100 may be loaded withmedication and encrypted to the user and the contents through a dockingstation into which the pill dispensing device 100 is inserted, and intowhich both medications are inserted and identity encryption takes place.The loading device may load one or more pills per cartridge compartmentand/or bulk load the housing, depending on the embodiment. For example,as depicted in FIG. 5, a loading or docking device 500 may be providedto receive a replaceable cartridge 114. The loading device 500 may beconfigured to insert a prescribed substance, such as pills, into thereplaceable cartridge 114 and/or into the pill dispensing device 100without a cartridge. The loading device 500 may be operated by apharmacist or other personnel responsible for distributing a prescribedsubstance or otherwise loading a replaceable cartridge 114 or the pilldispensing device 100 with a prescribed substance.

The loading device 500 may include a reader and/or programming device tofacilitate communication with the replaceable cartridge 114 and/or thepill dispensing device 100. The loading device 500 may include acommunication interface so that the intended patient can view and/orconfirm the information being encoded on the replaceable cartridge 114and/or the pill dispensing device 100. Moreover, the loading device 500may include an identification module configured to confirm the identityof the intended patient. For example, the verification module mayinclude, but is not limited to, fingerprint identification, pin codeencryption, face-recognition, voice-recognition, multi-sourceidentification software, and the like. In this manner, the intendedpatient may insert the replaceable cartridge 114 and/or the pilldispensing device 100 into the loading device 500, and the intendedpatient may confirm their identity with the identity verificationmodule. The pharmacist may insert pills into the loading device 500opposite the intended patient. The replaceable cartridge 114 and/or thepill dispensing device 100 may be loaded with medication and encryptedwith encryption information associated with the intended patient.

The remote monitoring component 112 may be configured to receive anindication when the pill dispensing device 100 is compromised. Forexample, one or more sensors may be associated with the anti-tamperingaspects of the pill dispensing device 100. If the sensors indicate thatthe pill dispensing device 100 is being tampered with, the remotemonitoring component 112 may send out a notification over the network116. In addition, in certain embodiments, the remote monitoringcomponent 112 may be configured to receive, by way of the network 116,an indication to dispense a prescribed substance at a time and/or dateother than a programmed time and/or date. In some instances, an alertmay be generated and transmitted by the processor and/or the remotemonitoring component 112 if the prescribed substance is dispensed at atime and/or date other than a programmed time and/or date, or if thepill dispensing device 100 is compromised or opened, or if someone otherthan the intended patient accesses or attempts to access the prescribedsubstance. In other instances, an alert may be generated and transmittedover the network 116 by the processor and/or the remote monitoringcomponent 112 indicating that the prescribed substance has been taken bythe intended patient or someone else. In one example, if the pilldispensing device 100 is compromised or otherwise dispenses a prescribedsubstance at a time and/or date other than a programmed time and/ordate, the prescribed substance may be rendered inert by the addition orrelease of a counter substance that may react with the prescribedsubstance to render it inert, inactive, or intolerable to one seeking toconsume it. In another example, remote monitoring component 112 maymonitor and/or transmit information regarding dispensing of themedication.

FIG. 2 schematically depicts systems, methods, and apparatuses forloading a replaceable cartridge 114. In some instances, a loading device234 may be provided to receive the replaceable cartridge 114 and toinsert a prescribed substance or the like into the multiple compartments126 of the replaceable cartridge 114. That is, the replaceable cartridge114 may be inserted and/or removed (by hand or automated) from theloading device 234. The loading device 234 may be operated by authorizedpersonnel, such as a physician or a pharmacist, responsible fordistributing a prescribed substance or otherwise loading the replaceablecartridge 114 with a prescribed substance. The loading device 234 mayinclude a reader and/or programming device 236 configured to facilitatecommunication with the replaceable cartridge 114. For example, thereader and/or programming device 236 may comprise one or more processorand/or memory configured to communication with the processor 130 and/ormemory 128 of the replaceable cartridge 114.

In certain embodiments, prescription information 238 may be providedover the network 116 to the loading device 234. For example, when apaper and/or electronic prescription 238 is received, prescriptioninformation 238 may be transmitted or otherwise input to the loadingdevice 234. The loading device 234 may transmit some or all of theprescription information 238 to the loading device 234. Prescriptioninformation 238 may include, but is not limited to, a name of aprescribed substance, a dosage regimen, a patient's contact information,a prescriber's contact information, etc. In this manner, the loadingdevice 234 may be automated to load the replaceable cartridge 114 inaccordance with the prescription information 238 received over thenetwork 116 by the loading device. In some instances, the loading device234 may be in communication with a computer 240 or the like to permitaccess to the prescription information 238 and/or to monitor, control,and/or otherwise communicate with the loading device 234.

FIG. 6 depicts an alternate configuration of a pill dispensing device600. For example, the pill dispensing device 600 may be configured toaccept (or house) a bottle 604 of medication, such as a standardmedicine bottle or the like. In this manner, the medicine bottle 604 (orcontainer) may be secured within a tamper proof enclosure to prevent thebottle 604 from being compromised. The pill dispensing device 600 mayinclude a smart capping/dispensing system 602 that regulates dispensingof the medication from the bottle 604. The smart cap 602 may include allof the tamper resistant functionality described above. For example, theintended user may have to provide identity verification, such as afinger print, pin code, etc. to access the medicine.

In some instances, the pill dispensing devices described herein mayinclude a plunger type mechanism configured to dispense medication. Forexample, the plunger may move downward with each dosage. Moreover, thepill dispensing devices may include a metered gate for dispensing themedication. The pill dispensing device may include a camera, a display,an identification number, wireless functionality, a USB port or thelike. In this manner, the pill dispensing device may be configured to beattached to a medication container or the like.

FIGS. 7-11 depict a pill dispensing device 700. In some instances, thepill dispensing device 700 may be configured to enclose (or surround) abottle 702 of medication, such as a standard medicine bottle or thelike. In this manner, the medicine bottle 702 (replaceable cartridge)may be secured within a tamper proof portable housing to prevent thebottle 702 from being compromised. For example, the pill dispensingdevice 700 may include a top portion 704 and a bottom portion 706 thatcollectively form a tamperproof portable housing about the bottle 702.In some instances, the top portion 704 may be mechanically secured (orlocked) to the bottom portion 706 to prevent unauthorized access to thecontents of the bottle 702.

In some instances, the bottom portion 706 may comprise a container 708sized and shaped to receive the bottle 702 therein. That is, the bottle702 may be at least partially positioned within the container 708. Incertain embodiments, the container 708 may be transparent so that anylabels on the bottle 702 may be visible from outside the container 708.In some instances, the bottle 702 maybe omitted. For example, theprescribed substance (e.g., pills) may be stored directly in thecontainer 708.

The pill dispensing device 700 may include a locking mechanismconfigured to secure the bottle 702 within the tamper proof enclosure toprevent the bottle 702 from being compromised. In an embodiment, thelocking mechanism may include a top flange 710, a spacer 712, a lockingring 714, and a bottom flange 716. The top flange 710 may include anumber of pins 718 extending therefrom. In some instances, an end 720 ofthe pins 718 may include a circumferential groove 722.

The bottom flange 716 may be disposed about the container 708. Thebottom flange 716 may include a number of bores 724 configured toreceive the ends 720 of the pins 718. That is, the bores 724 in thebottom flange 716 may correspond to the pins 718 extending from the topflange 710. In addition, the spacer 712 may include a number of passages726 that correspond to the pins 718 extending from the top flange 710.Accordingly, the pins 718 may pass through the passages 726 in thespacer 712. Moreover, the locking ring 714 may include a number ofopenings 728 that correspond to the pins 718 extending from the topflange 710. The pins 718 may pass through the openings 728 in thelocking ring 714.

When assembled, the top portion 704 and the bottom portion 706 may belocked together with the bottle 702 therein to form a portable housingenclosure. In other instances, the bottle 702 may be omitted, and thetop portion 704 and the bottom portion 706 may be locked together withthe prescribed substance disposed directly in the container 708.

To lock the top portion 704 to the bottom portion 706, the pins 718extending from the top flange 710 may pass through the passages 726 inthe spacer 712, through the openings 728 in the locking ring 714, andinto the bores 724 of the bottom flange 716. When assembled in thismanner, the circumferential grooves 722 disposed about the ends 720 ofthe pins 718 may be aligned with the locking ring 714. The locking ring714 may be rotated slightly so that a portion of the locking ring 714extends into the circumferential grooves 722 in the pins 718. This mayprevent movement of the pins 718, thereby locking the top portion 704 tothe bottom portion together 706. The locking ring 714 may be held inplace by any means known in the art, such as a radial ratchet-type lock,spring mechanism, or the like.

The pill dispensing device 700 may include a dispensing mechanism. Thedispensing mechanism may include a pill separation cone 730 and adispensing housing 732. The pill separation cone 730 may have a conicalportion 734 and tubular portion 736. The conical portion 734 may bedisposed about the bottle 702 (or the container 708 if the bottle 702 isomitted). The conical portion 734 may be configured to funnel pills (orother prescribed substances) to the tubular portion 736 from the bottle702 (or container 708). In some instances, the tubular portion 736 maybe sized to receive one pill at a time from the conical portion 734.

The dispensing housing 732 may include one or more electricalcomponents, a verification chamber 738, and an opening 740 fordispensing a pill. In some instances, the tubular portion 736 maydispense a pill into the verification chamber 738. The tubular portion736 may dispense a single pill into the verification chamber 738 ormultiple pills into the verification chamber 738. The verificationchamber 738 may include one or more sensors, such as infrared sensors,electromagnetic sensors, weight sensors, cameras, etc. Any devicecapable of sensing the presence of a prescribed substance within theverification chamber 738 may be used.

As noted above, the dispensing housing 732 may include an opening 740for dispensing a pill. In this manner, after a pill passes through theverification chamber 738, it may be dispensed to a verified user by wayof the opening 740. In certain embodiments, the opening 740,verification chamber 738, and the tubular portion 736 may be alignedsuch that a pill may be dispensed from the bottle 702 (or container708). If the opening 740, verification chamber 738, and the tubularportion 736 are not aligned, pills may not be dispensed. For example,the one or more electrical components within the dispensing housing 732may include an actuator or the like configured to control the positionof the pill separation cone 730. The actuator may move (or rotate) thepill separation cone 730 to enable the dispensing of pills or to preventthe dispensing of pills. In another embodiment, the actuator may movethe dispensing housing 732 about the pill separation cone 730, which maybe stationary. For example, FIG. 9 depicts the opening 740, theverification chamber 738, and the tubular portion 736 lined up such thata pill may be dispensed. In contrast, FIG. 10 depicts the opening 740,the verification chamber 738, and the tubular portion 736 offset fromone another such that a pill will not be dispensed. The actuator may bein communication with a controller. The controller may be configured toactivate the actuator as described above.

The pill dispensing device 700 may include all of the tamper resistantfunctionality described in the disclosure, including those describedwith reference to FIG. 1. For example, the intended user may have toprovide identity verification, such as a finger print, pin code, etc. toaccess the medicine. In some instances, a biometric identifier 742 maybe disposed about the dispensing housing 732. The biometric identifier742 may verify the identity of a user and instruct the controller todispense one or more pills. Moreover, the pill dispensing device 700 mayinclude a processor, a communication interface, a power source (e.g., abattery), and/or a remote monitoring component. In this manner, the pilldispensing device 700 may be in communication with other devices over anetwork or the like. In some instances, the pill dispensing device 700may notify a third party over the network the rate of pills beingdispensed or if the pill dispensing device 700 has been tampered with.In some instances, the pill dispensing device 700 may be programmed todispense a pill on a dosage schedule. For example, the pill dispensingdevice 700 may only enable a verified user to receive a pill during aspecified time frame.

FIGS. 12-14 depict a pill dispensing device 800. The pill dispensingdevice 800 is depicted with a side panel removed for clarity. The pilldispensing device 800 may include a portable housing having a pillstorage area 802, a drive mechanism area 804, and an electroniccomponents area 806. The pill storage area 802 may be configured tohouse one or more pills (or other prescribed substances) therein. Thedrive mechanism area 804 may be configured to house one or moreactuators or the like therein. The electronic components area 806 may beconfigured to house one or more electronics therein, such as aprocessor, a communication interface, a power source (e.g., a battery),and/or a remote monitoring component.

The pill storage area 802 may include a funnel-like shape 808 fordirecting one or more pills towards a ratchet assembly 810. In someinstances, the pill storage area 802 may include a plunger-like deviceor spring loaded device for urging the pills towards the ratchetassembly 810.

The ratchet assembly 810 may include a moveable arm 812. The moveablearm 812 may be in communication with an actuator or the like foradjusting the position of the movable arm 812. The moveable arm 812 maybe adjusted to enable one or more pills to pass from the pill storagearea 802 to a rotational pill exchange assembly 814. For example, themoveable arm 812 may be adjusted to enable multiple pills to pass to therotational pill exchange assembly 814, or the moveable arm 812 may beadjusted to limit a one pill at a time to pass to the rotational pillexchange assembly 814.

The rotational pill exchange assembly 814 may include a rotatable wheel816. The rotatable wheel 816 may include a cutout 818. The cutout 818may be configured to receive one or more pills from the ratchet assembly810. For example, as the rotatable wheel 816 rotates, the cutout 818 maypass by the ratchet assembly 810. Each time the cutout 818 passes theratchet assembly 810, it may receive one or more pills from the ratchetassembly 810. The cutout 818 may rotate from the ratchet assembly 810 toa validation port 820, where the pills may be transferred. That is, thecutout 818 may be configured to transfer one or more pills between theratchet assembly 810 and the validation port 820 as the rotatable wheels816 rotates.

In some instances, the rotational pill exchange assembly 814 may includeone or more sensors. For example, the sensors may detect the presence ofone or more pills in the cutout 818 before and after the validation port820. In this manner, the sensors may be configured to determine if apill was transferred from the cutout 818 to the validation port 820.Similarly, the validation port 820 may include one or more sensors. Thesensors in the validation port 820 may be configured to sense thepresence of one or more pills in the validation port 820.

The validation port 820 may be in communication with an opening 822 fordispensing one or more pills. The pill dispensing device 800 may includeall of the tamper resistant functionality described in the disclosure,including those described with reference to FIG. 1. For example, theintended user may have to provide identity verification, such as afinger print, pin code, etc. to access the medicine. Once the user isverified, a controller or the like may instruct the ratchet assemblyand/or the rotational pill exchange assembly to dispense one or morepills. Moreover, the pill dispensing device 800 may be in communicationwith other devices over a network or the like. In some instances, thepill dispensing device 800 may notify a third party over the network therate of pills being dispensed or if the pill dispensing device 800 hasbeen tampered with. In some instances, the pill dispensing device 800may be programmed to dispense a pill on a dosage schedule. For example,the pill dispensing device 800 may only enable a verified user toreceive a pill during a specified time frame.

FIGS. 15 and 16 depict a pill dispensing device 900 comprising aportable housing. The pill dispensing device 900 may include a pillstorage area 902. The pill dispensing device 900 also may include one ormore electronics, such as a processor, one or more actuators, acommunication interface, a power source (e.g., a battery), and/or aremote monitoring component.

The pill storage area 902 may include a funnel-like shape 904 fordirecting one or more pills towards a rotational pill exchange assembly906. In some instances, the pill storage area 902 may include aplunger-like device or spring loaded device for urging the pills towardsthe rotational pill exchange assembly 906.

The rotational pill exchange assembly 906 may include a rotatable wheel908. The rotatable wheel 908 may include one or more cutouts 910. Inother instances, the rotatable wheel 908 may include a single cutoutsimilar to the cutout 818 described above. The cutouts 910 may beconfigured to receive one or more pills from the pill storage area 902.For example, as the rotatable wheel 908 rotates, the cutouts 910 maypass by the pill storage area 902. Each time the cutouts 910 pass thepill storage area 902, they may receive one or more pills from the pillstorage area 902. The cutouts 910 may rotate from the pill storage area902 to a channel 914, where the pills may be transferred. That is, thecutouts 910 may be configured to transfer one or more pills between thepill storage are 902 and the channel 914 as the rotatable wheels 908rotates.

In some instances, the rotational pill exchange assembly 906 may includeone or more sensors 912. For example, the sensors 912 may detect thepresence of one or more pills in the cutouts 910 before and after eachcutout passes the channel 914. In this manner, the sensors 912 may beconfigured to determine if a pill was transferred from the cutouts 910to the channel 914. In one example, the sensors 912 may detect thepresence of one or more pills within the cutouts 910 before the channel914. Moreover, the sensors 912 may detect the absence of one or morepills within the cutouts 910 after the channel 914, which may indicatethe pills were dispensed.

The channel 914 may be in communication with an opening 916 fordispensing one or more pills. In some instances, the channel 914 may becurved to prevent tampering with the device. The pill dispensing device900 may be similar to the pill dispensing device 800. That is, thevarious components of the pill dispensing device 800 may be included oromitted from the pill dispensing device 900 and vice versa. For example,the ratchet assembly described above may be incorporated into the pilldispensing device 900.

The pill dispensing device 900 may include all of the tamper resistantfunctionality described in the disclosure, including those describedwith reference to in FIG. 1. For example, the intended user may have toprovide identity verification, such as a finger print, pin code, etc. toaccess the medicine. Once the user is verified, a controller or the likemay instruct the rotational pill exchange assembly to dispense one ormore pills. Moreover, the pill dispensing device 900 may be incommunication with other devices over a network or the like. In someinstances, the pill dispensing device 900 may notify a third party overthe network the rate of pills being dispensed or if the pill dispensingdevice 900 has been tampered with. In some instances, the pilldispensing device 900 may be programmed to dispense a pill on a dosageschedule. For example, the pill dispensing device 900 may only enable averified user to receive a pill during a specified time frame.

FIGS. 17 and 18 depict a cassette-like mechanism 1000 for dispensing oneor more pills (or other prescribed substances) securely. Thecassette-like mechanism 1000 may be used in any of the embodimentsdescribed herein. For example, the cassette-like mechanism 1000 may beused to dispense one or more pills from a tamperproof portable housing.The tamperproof portable housing may include all of the functionalitydescribed in the disclosure, including those described with reference toFIG. 1.

In certain embodiments, the cassette-like mechanism 1000 may include acontinuous track 1002 disposed about two or more wheels 1004. Thecontinuous track 1002 may include an outer track 1006 and an inner track1008. In some instances, the outer track 1006 may be stationary, and theinner track 1008 may rotate about the wheels 1004. In other instances,both the inner track 1008 and the outer track 1006 may rotate about thewheels 1004. A number of spacers 1010 may extend between the inner track1008 and the outer track 1006. A number of chambers 1012 may be definedbetween adjacent spacers 1010. Each chamber 1012 may be configured tohouse one or more pills therein. As the inner track 1008 rotates aboutthe wheels 1004, the chambers 1012 may rotate as well. In this manner,the chambers 1012 may move the pills along the continuous track's path.In some instances, the portable housing may include an opening. As thechambers 1012 rotate past the opening, the pills may be accessible fromoutside the enclosure. The cassette-like mechanism 1000 may beincorporated into any of the embodiments discussed in the disclosure.

Illustrative Methods

FIG. 3 is a flow diagram depicting an illustrative method 300 forsecurely dispensing one or more prescribed substances at a given timeand/or date in accordance with one or more embodiments of thedisclosure.

At block 302 of method 300, a portable housing 102 may be provided thatis generally tamper-proof and may only be opened by authorizedpersonnel, such as a physician or a pharmacist. In some instances, theportable housing 102 may be sized and shaped to be carried by a patient.For example, the portable housing 102 may be configured to be held inthe hand of the patient and/or carried in the pocket of the patient. Atblock 304 of method 300, a replaceable cartridge 114 may be positionedwithin the portable housing 102. The replaceable cartridge 114 maycomprise a removable cartridge with multiple compartments 126 or asingle compartment configured to hold predefined amounts of theprescribed substance. The replaceable cartridge 114 may be generallytamper-proof and only accessible by authorized personnel uponverification thereof. The replaceable cartridge 114 may be operable todispense a predefined amount of a prescribed substance at a given timeand/or date or on demand. For example, the replaceable cartridge 114 maycooperate with the portable housing 102 to enable a patient to access apredefined amount of a prescribed substance at a given time and/or date.

At block 306 of method 300, the portable housing 102 and/or thereplaceable cartridge 114 may be programmed to dispense the prescribedsubstance. That is, in certain embodiments, authorized personnel mayprogram the processor 130 and/or memory 128 associated with thereplaceable cartridge 114 to communicate with the processor 106 and/orthe memory 104 associated with the portable housing 102 to provide thepatient with a predefined amount of a prescribed substance at a giventime and/or date. For example, the replaceable cartridge 114 may providea predefined amount of a prescribed substance to the access port 132within the portable housing 102 that is accessible by the patient at thegiven time and/or date based on the instructions provided by theauthorized personnel. In some instances, an operator of the authorizeduser system 118 may remotely modify the programmed medication scheduleof the pill dispensing device 100.

At block 308 of method 300, the pill dispensing device 100 may dispenseone or more prescribed substances. For example, the pill dispensingdevice 100 may dispense one or more prescribed substances based on (1)programmed instructions in the memory and/or processors, (2) anauthorization to dispense the prescribed substance received over thenetwork 116, and/or (3) upon verification of the patient, etc. The stepsdescribed in blocks 302-308 of method 300 may be performed in any order.Moreover, certain steps may be omitted, while other steps may be added.

FIG. 4 is a flow diagram depicting an illustrative method 400 forsecurely dispensing one or more prescribed substances at a given timeand/or date in accordance with one or more embodiments of thedisclosure.

At block 402 of method 400, the replaceable cartridge 114 may bepositioned within the portable housing 102 by way of an opening 122.After positioning the replaceable cartridge 114 within the portablehousing 102, the replaceable cartridge 114 may be secured within theportable housing 102 at block 404. For example, the opening 122 mayinclude a locking mechanism 124 or the like. In some instances, thelocking mechanism 124 may be a mechanical lock, a biometric lock, anelectronic lock, or a combination thereof. For example, a personauthorized to insert and/or remove the replaceable cartridge 114 may berequired to enter a code, provide a finger print, and/or use a key toaccess the opening 122 to remove or insert the replaceable cartridge114. Any biometric identifier may be used. For example, in someinstances, the locking mechanism 124 may comprise voice recognitionsoftware. That is, a person authorized to insert and/or remove thereplaceable cartridge 114 may speak into the communication interface 108and/or the user device 120 in order to unlock the locking mechanism 124.Other locking mechanisms 124 may also be used to prevent tampering withthe opening 122.

At block 406 of method 400, an alert may be generated and transmitted bythe processor and/or the remote monitoring component 112 if theprescribed substance is dispensed at a time and/or date other than aprogrammed time and/or date, or if the portable housing 102 and/orreplaceable cartridge 114 is compromised or opened, or if someone otherthan the patient accesses or attempts to access the prescribedsubstance. The steps described in blocks 402-406 of method 400 may beperformed in any order. Moreover, certain steps may be omitted, whileother steps may be added.

Although specific embodiments of the disclosure have been described,numerous other modifications and alternative embodiments are within thescope of the disclosure. For example, any of the functionality describedwith respect to a particular device or component may be performed byanother device or component. Further, while specific devicecharacteristics have been described, embodiments of the disclosure mayrelate to numerous other device characteristics. Further, althoughembodiments have been described in language specific to structuralfeatures and/or methodological acts, it is to be understood that thedisclosure is not necessarily limited to the specific features or actsdescribed. Rather, the specific features and acts are disclosed asillustrative forms of implementing the embodiments. Conditionallanguage, such as, among others, “can,” “could,” “might,” or “may,”unless specifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments could include, while other embodiments may not include,certain features, elements, and/or steps. Thus, such conditionallanguage is not generally intended to imply that features, elements,and/or steps are in any way required for one or more embodiments.

We claim:
 1. A pill dispensing device, comprising: a portable housingenclosure comprising a top portion and a bottom portion, wherein thebottom portion comprises a container; a dispensing mechanism comprisinga pill separation cone and a dispensing housing; and a locking mechanismconfigured to secure the top portion to the bottom portion, wherein thelocking mechanism comprises a top flange, a spacer, a locking ring, anda bottom flange, wherein the top flange comprises a plurality of pinsextending therefrom, wherein an end of each of the plurality of pinscomprises a circumferential groove, wherein the locking ring isconfigured to be rotated so that a portion of the locking ring extendsinto each circumferential groove in the plurality of pins to lock thetop portion to the bottom portion, wherein the pill separation conecomprises a conical portion and tubular portion, and wherein the conicalportion is disposed about the container and configured to funnel pillsto the tubular portion from the container.
 2. The device of claim 1,wherein the container is sized and shaped to receive a bottle therein.3. The device of claim 2, wherein the bottom flange is disposed aboutthe container.
 4. The device of claim 3, wherein the bottom flangecomprises a plurality of bores configured to receive the ends of theplurality of pins.
 5. The device of claim 4, wherein the spacercomprises a plurality of passages.
 6. The device of claim 5, wherein thelocking ring comprises a plurality of openings.
 7. The device of claim6, wherein the locking mechanism comprises a locked position in whichthe top portion is locked to the bottom portion.
 8. The device of claim7, wherein when in the locked position, the plurality of pins extendthrough the plurality of passages, through the plurality of openings,and into the plurality of bores.
 9. The device of claim 7, wherein whenin the locked position, the circumferential grooves disposed about theends of the plurality of pins align with the locking ring.
 10. Thedevice of claim 1, wherein the tubular portion is sized to receive onepill at a time from the conical portion.
 11. The device of claim 1,wherein the dispensing housing comprises a verification chamber and anopening for dispensing the pills.
 12. The device of claim 11, whereinthe tubular portion is configured to dispense a single pill into theverification chamber or multiple pills into the verification chamber.13. The device of claim 11, wherein the verification chamber comprisesone or more sensors configured to sense the presence of one or morepills within the verification chamber.
 14. The device of claim 11,wherein the pill separation cone and/or the dispensing housing isrotatable.
 15. The device of claim 14, wherein the dispensing mechanismcomprises a first configuration in which the opening, the verificationchamber, and the tubular portion are configured to be aligned such thata pill is able to be dispensed from the container.
 16. The device ofclaim 14, wherein the dispensing mechanism comprises a secondconfiguration in which the opening, the verification chamber, and thetubular portion are not aligned such that a pill cannot be dispensedfrom the container.
 17. A pill dispensing device, comprising: a portablehousing enclosure comprising a top portion and a bottom portion, whereinthe bottom portion comprises a container; a locking mechanism configuredto secure the top portion to the bottom portion; and a dispensingmechanism, comprising a pill separation cone, and a dispensing housing,wherein the pill separation cone comprises a conical portion and tubularportion, wherein the conical portion is disposed about the container andconfigured to funnel pills to the tubular portion from the bottomportion, wherein the locking mechanism comprises a top flange, a spacer,a locking ring, and a bottom flange, wherein the top flange comprises aplurality of pins extending therefrom, wherein an end of each of theplurality of pins comprises a circumferential groove, wherein the bottomflange is disposed about the container, wherein the bottom flangecomprises a plurality of bores configured to receive the ends of theplurality of pins, wherein the spacer comprises a plurality of passages,wherein the locking ring comprises a plurality of openings, wherein thelocking mechanism comprises a locked position in which the top portionis locked to the bottom portion, and wherein when in the lockedposition, the plurality of pins extend through the plurality ofpassages, through the plurality of openings, and into the plurality ofbores.